News & Analysis as of

Policies and Procedures Final Rules Department of Health and Human Services (HHS)

Epstein Becker & Green

The Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms

Epstein Becker & Green on

When the current federal administration took office, it issued a memorandum requiring, among other things, that federal agencies delay the issuance of new or proposed rules to the Office of the Federal Register until further...more

BakerHostetler

What’s Hot in Healthcare: Digital Health Regulatory Update

BakerHostetler on

As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more

Bradley Arant Boult Cummings LLP

Group Health Plan Sponsors Take Note: New Developments Relating to the Privacy and Cybersecurity of Plan Participants’ Health...

There have been two important developments in the law applicable to the privacy and cybersecurity of group health plan participants’ health information. Plan sponsors must review plan policies and procedures, provider...more

Health Care Compliance Association (HCCA)

New ORI Misconduct Rule Offers ‘Thoughtful’ Revisions in Wake of Highly Criticized NPRM

Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...more

Health Care Compliance Association (HCCA)

ORI’s Garrity: Final Rule ‘Walks Delicate Line’

Sheila Garrity, director of the HHS Office of Research Integrity (ORI), recently spoke to RRC about the agency‘s new rule revising research misconduct regulations, which has a compliance date of Jan. 1, 2026 (see related...more

Hinckley Allen

ORI Issues Final Revisions to 2005 PHS Research Misconduct Regulations

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On September 12, 2024, the U.S. Department of Health and Human Services (“HHS”), through the Office of Research Integrity (“ORI”) issued its Final Rule, the long-anticipated update to the 2005 Public Health Service Policies...more

Jenner & Block

Client Alert: The Department of Health and Human Services Issues HIPAA Final Rule Providing Additional Reproductive Health...

Jenner & Block on

On April 26, 2024, the Department of Health and Human Services (HHS) published the final HIPAA Privacy Rule to Support Reproductive Health Care Privacy (Final Rule). The Final Rule became effective June 25, 2024....more

Verrill

HHS Issues Model Attestation Required by Final HIPAA Regulations Supporting Reproductive Health Care Privacy

Verrill on

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) and Office for Civil Rights (OCR) published Final Regulations under HIPAA’s Privacy Rule introducing greater protections for information related to...more

Holland & Hart - The Benefits Dial

P-R-I-V-A-C-Y is Priceless to Me: The 2024 Privacy Rule

The Department of Health and Human Services issued a final rule amending the HIPAA privacy rules (“2024 Privacy Rule”). The 2024 Privacy Rule limits the use or disclosure of an individual’s PHI in connection with reproductive...more

Polsinelli

HHS Finalized Part 2 Revisions: What Has Changed?

Polsinelli on

On February 8, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), released final rule (Final Rule)...more

Ankura

Updates to the Translation and Accessibility Standards for Required Materials and Content in the Medicare 2024 Final Rule

Ankura on

Medicare Advantage Organizations and Part D sponsors have a responsibility to ensure they offer and provide their members and potential enrollees with content and materials in alternate languages or accessible formats for...more

McDermott Will & Emery

California DxF Policies and Procedures Released for Public Comment

McDermott Will & Emery on

On January 17, 2023, the California Health and Human Services Agency (CalHHS) released updated drafts of four policies and procedures (P&Ps) under the California Data Exchange Framework (DxF) to support the implementation of...more

White and Williams LLP

Information Blocking: What Providers And Programmers Need To Know

White and Williams LLP on

Federal enforcement of the 21st Century Cures Act’s (the Cures Act) prohibitions on improper blocking of electronic health information is ramping up. The Cures Act already targets technology developers and health information...more

Bricker Graydon LLP

HHS releases final rules on interoperability and information blocking

Bricker Graydon LLP on

On March 9, 2020, two final rules on electronic health information were issued by the Office of National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS)....more

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